Initial results
from a large, randomized
clinical trial for
people with multiple
myeloma showed that people
who received the oral drug lenalidomide
(Revlimid, also known as CC-5013)
following a blood stem cell transplant
had their cancer kept in check longer
than those who received a placebo.

The clinical trial, for people with
multiple myeloma ages 18 to 70, was
sponsored by the National Cancer Institute,
and conducted by a network of
researchers led by the Cancer and Leukemia
Group B in collaboration with the
Eastern Cooperative Oncology Group
and the Blood and Marrow Transplant
Clinical Trials Network.

The independent data and safety
monitoring committee overseeing the
trial (known as CALGB-100104) found
that the study demonstrated a longer
time before the cancer progressed following
autologous blood stem cell
transplantation for those people on the
study drug than those on placebo; therefore,
the trial was stopped early.

Among the participants who received
placebo, half had their myeloma progress
(worsen) within an estimated 778 days.
In contrast, for those taking lenalidomide,
a median time to progression cannot be
defined because fewer than half had
worsening of their myeloma. This represents
a 58 percent reduction in the
risk of disease progression for the
group taking lenalidomide. This difference
in time to progression was highly
statistically significant.

This is the first randomized Phase III
trial (the final and most comprehensive
aspect of a three-phase clinical trials process)
to demonstrate a clinical benefit
of lenalidomide following transplant
for multiple myeloma. However, the
trial has not yet shown evidence of an
overall survival benefit.

“This study answers the important
question for multiple myeloma patients
regarding maintenance lenalidomide
therapy starting at 100 days following
transplant,” says Philip L. McCarthy
Jr., MD, associate professor of Medicine
at Roswell Park Cancer Institute
and principal investigator of this
study. “We now know that prolonged
maintenance therapy with lenalidomide
when compared to placebo will
delay disease progression. This is an
exciting advance in the field of multiple
myeloma therapy and occurred
due to the willingness of multiple
myeloma patients to participate in
this study and to the cooperation
of the many physicians and study
groups involved.”

Lenalidomide, a derivative of thalidomide,
was approved by the U.S. Food
and Drug Administration in 2006 to be
used in combination with dexamethasone,
a steroid, for the treatment of
multiple myeloma in people who received
at least one prior therapy for
their disease.